NCT00075647

CCI-779 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

Phase II Trial of CCI-779 in Locally Advanced or Metastatic Pancreatic Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Drugs used in chemotherapy, such as CCI-779, work in different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well CCI-779 works in treating patients with locally advanced or metastatic pancreatic cancer

Detailed description

PRIMARY OBJECTIVES: I. Determine the overall survival at 6 months in patients with locally advanced or metastatic pancreatic cancer treated with CCI-779. SECONDARY OBJECTIVES: I. Determine time to progression, progression-free survival, overall survival, and tumor response rate in patients with measurable disease treated with this drug. II. Correlate biomarkers of response with clinical response in patients treated with this drug. III. Determine the safety and toxicity of this drug in these patients. OUTLINE: This is an open-label study. Patients receive CCI-779 IV over 30 minutes once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 13 months.

Conditions

• Adenocarcinoma of the Pancreas
• Recurrent Pancreatic Cancer
• Stage II Pancreatic Cancer
• Stage III Pancreatic Cancer
• Stage IV Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	temsirolimus	Given IV
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2003-12-01
• Primary completion: 2005-03-01
• First posted: 2004-01-12
• Last updated: 2013-01-17

Locations

1 site across 1 country: United States